Detailed description page of THPdb

Details of Th1138 which contains 1 entries.

Entry 1
(1) Primary information
ID 1627
ThPP ID Th1138
Therapeutic Peptide/Protein Name Raxibacumab
Sequence N.A. view full sequnce in fasta
Functional Classification IIa
Molecular Weight 142844.5367
Chemical Formula C6320H9794N1702O1998S42
Isoelectric Point N.A.
Hydrophobicity N.A.
Melting Point (℃) N.A.
Half Life Elimnation half life-IM dose- 15-19 days; IV dose-16-19 days
Description Recombinant (murine cell line derived), human IgG1 monoclonal antibody that binds the protective antigen (PA) component of B. anthracis toxin. FDA approved on December 14, 2012.
Indication/Disease Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
Pharmacodynamics N.A.
Mechanism of Action Raxibacumab is a monoclonal antibody that binds free PA with an affinity equilibrium dissociation constant (Kd) of 2.78 Â± 0.9 nM. Raxibacumab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin. It does not have direct antibacterial activity.
Toxicity The most frequently reported adverse reactions were rash, pain in extremity, pruritus, and somnolence.
Metabolism N.A.
Absorption Raxibacumab does not cross the blood-brain-barrier. When a single IV dose of 40 mg/kg was administered to healthy, male and female human subjects, the pharmacokinetic parameters are as follows: Cmax = 1020.3 Â± 140.6 mcg/mL; AUCinf = 15845.8 Â± 4333.5 mcgÂ·day/mL.; Bioavailability is also dependent on site of injection. When administered to the vastus lateralis, the bioavailability is 71-85%. When administered to the gluteus maximus, the bioavailability is 50-54%.
Volume of Distribution Steady state volume of distribution exceeded plasma volume. This suggests that there is some distribution into the tissues.
Clearance Clearance values were much smaller than the glomerular filtration rate indicating that there is virtually no renal clearance of raxibacumab.
Categories Anti-Infective Agents and Monoclonal antibodies
Patents Number N.A.
Date of Issue N.A.
Date of Expiry N.A.
Drug Interaction N.A.
Target Protective antigen
Information of corresponding available drug in the market
Brand Name RAXIBACUMAB
Company GSK
Brand Discription Raxibacumab is a human IgG1Î» monoclonal antibody that binds the PA component of B. anthracis toxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system.
Prescribed for Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate
Chemical Name N.A.
Formulation Single-use vial contains 1700 mg/34 mL (50 mg/mL) raxibacumab solution.
Physcial Appearance Raxibacumab is supplied as a sterile, liquid formulation in single-dose vials for Intravenous infusion. Each vial contains 50 mg/mL raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), and sucrose (10 mg/mL), with a pH of 6.5. Eac
Route of Administration N.A.
Recommended Dosage Premedicate with diphenhydramine. Dilute and administer as an Intravenous infusion over 2 hours and 15 minutes. Adults: 40 mg/kg raxibacumab. Pediatrics greater than 50 kg: 40 mg/kg raxibacumab. Pediatrics greater than 15 kg to 50 kg: 60 mg/kg raxibacumab. Pediatrics 15 kg or less: 80 mg/kg raxibacumab.
Contraindication There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs. Nursing Mothers: Caution should be exercised when administered to a nursing woman. Pediatric Use: Safety and effectiveness in children <16 years of age not studied.
Side Effects Infusion reactions may occur. Premedicate with diphenhydramine. Slow or interrupt infusion and administer treatment based on severity of the reaction. Common adverse reactions in healthy adult subjects (â‰¥1.5%) were: rash, pain in extremity, pruritus, and somnolence.
Useful Link http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332341.htm,
PubMed ID 25487792, 24812521, 23545582, 23344456, 20068396
3-D Structure N.A.

OSDDlinux

Raghava's Group

IMTECH

CSIR

CRDD
CPPSITE 2.0

(1) Primary information
Entry 1
ID	1627
ThPP ID	Th1138
Therapeutic Peptide/Protein Name	Raxibacumab
Sequence	N.A. view full sequnce in fasta
Functional Classification	IIa
Molecular Weight	142844.5367
Chemical Formula	C6320H9794N1702O1998S42
Isoelectric Point	N.A.
Hydrophobicity	N.A.
Melting Point (℃)	N.A.
Half Life	Elimnation half life-IM dose- 15-19 days; IV dose-16-19 days
Description	Recombinant (murine cell line derived), human IgG1 monoclonal antibody that binds the protective antigen (PA) component of B. anthracis toxin. FDA approved on December 14, 2012.
Indication/Disease	Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
Pharmacodynamics	N.A.
Mechanism of Action	Raxibacumab is a monoclonal antibody that binds free PA with an affinity equilibrium dissociation constant (Kd) of 2.78 Â± 0.9 nM. Raxibacumab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin. It does not have direct antibacterial activity.
Toxicity	The most frequently reported adverse reactions were rash, pain in extremity, pruritus, and somnolence.
Metabolism	N.A.
Absorption	Raxibacumab does not cross the blood-brain-barrier. When a single IV dose of 40 mg/kg was administered to healthy, male and female human subjects, the pharmacokinetic parameters are as follows: Cmax = 1020.3 Â± 140.6 mcg/mL; AUCinf = 15845.8 Â± 4333.5 mcgÂ·day/mL.; Bioavailability is also dependent on site of injection. When administered to the vastus lateralis, the bioavailability is 71-85%. When administered to the gluteus maximus, the bioavailability is 50-54%.
Volume of Distribution	Steady state volume of distribution exceeded plasma volume. This suggests that there is some distribution into the tissues.
Clearance	Clearance values were much smaller than the glomerular filtration rate indicating that there is virtually no renal clearance of raxibacumab.
Categories	Anti-Infective Agents and Monoclonal antibodies
Patents Number	N.A.
Date of Issue	N.A.
Date of Expiry	N.A.
Drug Interaction	N.A.
Target	Protective antigen
Information of corresponding available drug in the market
Brand Name	RAXIBACUMAB
Company	GSK
Brand Discription	Raxibacumab is a human IgG1Î» monoclonal antibody that binds the PA component of B. anthracis toxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system.
Prescribed for	Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate
Chemical Name	N.A.
Formulation	Single-use vial contains 1700 mg/34 mL (50 mg/mL) raxibacumab solution.
Physcial Appearance	Raxibacumab is supplied as a sterile, liquid formulation in single-dose vials for Intravenous infusion. Each vial contains 50 mg/mL raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), and sucrose (10 mg/mL), with a pH of 6.5. Eac
Route of Administration	N.A.
Recommended Dosage	Premedicate with diphenhydramine. Dilute and administer as an Intravenous infusion over 2 hours and 15 minutes. Adults: 40 mg/kg raxibacumab. Pediatrics greater than 50 kg: 40 mg/kg raxibacumab. Pediatrics greater than 15 kg to 50 kg: 60 mg/kg raxibacumab. Pediatrics 15 kg or less: 80 mg/kg raxibacumab.
Contraindication	There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs. Nursing Mothers: Caution should be exercised when administered to a nursing woman. Pediatric Use: Safety and effectiveness in children <16 years of age not studied.
Side Effects	Infusion reactions may occur. Premedicate with diphenhydramine. Slow or interrupt infusion and administer treatment based on severity of the reaction. Common adverse reactions in healthy adult subjects (â‰¥1.5%) were: rash, pain in extremity, pruritus, and somnolence.
Useful Link	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332341.htm,
PubMed ID	25487792, 24812521, 23545582, 23344456, 20068396
3-D Structure	N.A.